Full Press Release Details
Synthetic Biologics Reports Third Quarter
2017 Operational Highlights and Financial Results
- Strengthened Balance Sheet in Support
of Microbiome-Focused Clinical Development Programs -
Type-B Multidisciplinary Meeting with FDA to Discuss Late-Stage
Clinical Advancement
for SYN-004 (ribaxamase) -
- Conference Call Today, November
1, 2017, at 4:30 p.m. EDT -
MD, November 1, 2017 - Synthetic Biologics, Inc. (NYSE American: SYN), a late-stage
clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, today provided
an operational update and reported financial results for the three months ended September 30, 2017.
"During the third quarter, we remained
keenly focused on the advancement of our two-lead microbiome-focused clinical programs," said Jeff Riley, President and Chief
Executive Officer of Synthetic Biologics. "Following the successful completion of a Phase 2b proof-of-concept clinical study
and the announcement of Breakthrough Therapy Designation for SYN-004 (ribaxamase), we held an initial Type-B multidisciplinary
meeting with the U.S. Food and Drug Administration (FDA) to discuss the overarching, high-level drug development plan and pathway
towards marketing approval for ribaxamase. We look forward to further collaborative discussions with the FDA on the development
of a regulatory pathway forward for this novel approach to preventing the onset of primary C. difficile infection and the
emergence of antimicrobial resistance."
Mr. Riley continued, "While continuing
to focus on our clinical development activities during the third quarter, we also successfully strengthened our balance sheet with
the announcement of a privately placed $12 million convertible preferred stock financing with an affiliate of MSD Partners, L.P.
We intend to build upon the momentum of the third quarter and continue to seek to build value for our shareholders as part our
transition from an early-stage clinical development company, to a late-stage company focused on the commercialization of our two-promising
microbiome-focused drug candidates."
Clinical Development & Operational
Third Quarter 2017 Financial Results
General and administrative expenses decreased
by 19% to $1.7 million for the third quarter of 2017, from $2.1 million for the third quarter of 2016. This decrease is primarily
the result of higher salary expense and related benefits costs incurred in 2016 in connection with the transition of the administrative
and financial office to our Maryland headquarters, along with a reduction of travel, registration fees and legal expenses in 2017.
The charge related to stock-based compensation expense was $583,000 for the third quarter of 2017, compared to $524,000 for the
third quarter of 2016.
Research and development expenses decreased
by 41% to $4.1 million for the third quarter of 2017, from $7.1 million for the third quarter of 2016. This decrease is primarily
the result of lower SYN-004 (ribaxamase) and SYN-010 program costs. In addition, there were reductions in our other research and
development activities, offset by an increase in indirect costs for manufacturing and medical affairs. Research and development
expenses also include a charge related to stock-based compensation expense of $317,000 for the third quarter of 2017, compared
to $422,000 for the third quarter of 2016.
Other expense was $5.1 million for the
third quarter of 2017, compared to other income of $0.7 million for the third quarter of 2016. Other expense for the third quarter
of 2017 is primarily comprised of non-cash expense of $5.1 million from the change in the fair value of warrants. The increase
in the fair value of the warrants was due to the increase in our stock price from the prior quarter.
Cash and cash equivalents as of September
30, 2017 were approximately $21.1 million, an increase of $2.0 million from December 31, 2016.
Synthetic Biologics will hold a conference
call today, Wednesday, November 1, 2017, at 4:30 p.m. EDT. The dial-in information for
the call is as follows: U.S. toll free: 1-888-347-5280 and International: +1 412-902-4280.
Participants are asked to dial in 15 minutes
before the start of the call to register. The call will also be webcast over the Internet at https://www.webcaster4.com/Webcast/Page/1096/23123.
An archive of the conference call will be available for approximately 90 days at the same URL, https://www.webcaster4.com/Webcast/Page/1096/23123
beginning approximately one hour after the call's conclusion.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American:
SYN) is a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of
patients. The Company's lead candidates poised for Phase 3 development are: (1) SYN-004 (ribaxamase) which is designed to protect
the gut microbiome from the effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C.
difficile infection (CDI), overgrowth of pathogenic organisms and the emergence of antimicrobial resistance (AMR), and (2)
SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause
of irritable bowel syndrome with constipation (IBS-C). The Company is also developing preclinical stage monoclonal antibody therapies
for the prevention and treatment of pertussis and novel discovery stage biotherapeutics for the treatment of phenylketonuria (PKU).
For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.
This press release includes forward-looking
statements on Synthetic Biologics' current expectations and projections about future events. In some cases, forward-looking
statements can be identified by terminology such as "may," "should," "potential," "continue,"
"expects," "anticipates," "intends," "plans," "believes," "estimates,"
and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number
of risks and uncertainties, many of which are difficult to predict and include statements regarding the expectation of further
collaborative discussions with the FDA on the development of a regulatory pathway forward for SYN-004 (ribaxamase), the intent
to build upon the momentum of Synthetic Biologics' third quarter and continue to build value for shareholders, Synthetic Biologics'
plans to initiate Phase 3 clinical trial(s) in 2018 for SYN-004 (ribaxamase), the expectation of sharing additional results regarding
several exploratory endpoints from the SYN-004 Phase 2b proof-of-concept clinical trial, and the expectation of continuing to solidify
Synthetic Biologics' clinical infrastructure to support successful advancement of SYN-010. These forward-looking statements are
based on management's expectations and assumptions as of the date of this press release and are subject to a number of substantial
risks and uncertainties, many of which are difficult to predict and could cause actual results to differ materially and adversely
from current expectations and assumptions from those set forth, projected or implied by any forward-looking statements. Important
factors that could cause actual results to differ materially from current expectations include, among others, Synthetic Biologics'
product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results, Synthetic
Biologics' ability to initiate clinical trials and if initiated, to complete them on time and achieve desired results and benefits,
Synthetic Biologics' clinical trials continuing enrollment as expected, Synthetic Biologics' ability to obtain regulatory approvals
for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating
to Synthetic Biologics' ability to promote or commercialize its product candidates for specific indications, acceptance of its
product candidates in the marketplace and the successful development, marketing or sale of Synthetic Biologics' products by competitors
that render Synthetic Biologics' products obsolete or non-competitive, Synthetic Biologics' ability to maintain its license agreements,
the continued maintenance and growth of Synthetic Biologics' patent estate, Synthetic Biologics becoming and remaining profitable,
Synthetic Biologics' ability to establish and maintain collaborations, Synthetic Biologics' ability to obtain or maintain
the capital or grants necessary to fund its research and development activities, a loss of any of Synthetic Biologics' key
scientists or management personnel, and other factors described in Synthetic Biologics' Annual Report on Form 10-K for the
year ended December 31, 2016, and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K.
The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation
to revise or update any forward-looking statements contained in this release on account of new information, future events, or otherwise,
except as required by law.
For further information, please contact:
Synthetic Biologics, Inc. (Corporate and
Vincent I. Perrone, Director, Corporate
Communication, (240) 660-2000, info@syntheticbiologics.com
Feinstein Kean Healthcare (Media)
Gregory Kelley, Senior Vice President,
(404) 836-2302, gregory.kelley@fkhealth.com